Intervertebral Disc Aspiration

Intervertebral Disc Aspiration

Intervertebral disc aspiration involves placement of a needle into the disc space with aspiration, and
washings, in an attempt to gain enough sample to evaluate for the possibility of disc infection. 

CPT 62267 - Percutaneous aspiration within the nucleus pulposus, intervertebral disc, or paravertebral tissue for diagnostic purposes.

For imaging, use 77003 - Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid).

Procedure Description:

The physician positions the patient on his side or lying face down and after prepping and draping the patient, administers a local anesthetic at the proposed puncture site. Using fluoroscopy or computed tomography imaging guidance, the physician then introduces a hollow needle into the spinal column at the puncture site. then advances the needle until she positions it in the disc or in the surrounding tissue. Then he verifies the needle placement using CT or fluoroscopic imaging then uses the needle to aspirate fluid and or cells, moving the needle and taking samples as necessary. he sends samples to the laboratory for diagnostic testing. Finally, he withdraws the needle and applies a sterile dressing.

CPT 62287 - Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with the use of an endoscope, with discography and/or epidural injections at the treated levels, when performed, single or multiple levels, lumbar

Procedure Description:

Patient is appropriately prepped and anesthetized, the physician uses one of several methods to decompress or remove disc material from a disc that is protruding through two or more vertebrae in the lumbar portion of the spine. In any method, using fluoroscopy, the physician injects contrast into the gel like center, or nucleus, of the suspect spinal disc to better visualize the disc and protruding material, known as discography. The physician also uses an endoscope and fluoroscopy guidance, along with a local epidural anesthetic injection, to perform a lumbar decompression. In this procedure, the physician places the patient on a radiolucent table and inserts a needle through a stab wound in the flank, or side of the patient and guides the needle into the disc interspace, being careful not to puncture the dura. After puncturing the disc, he confirms the proper positioning of the needle using fluoroscopic images. Next, he either manually, or using an automated device, radiofrequency, or laser energy, aspirates disc tissue, removing as much material as he safely can until he decompresses the nerve.

Note:

If deep bone biopsy of the vertebral body end plate and percutaneous disc aspiration are performed
at the same level, use code 20225 to describe the procedure. Do not use code 62267 in this case.

Do not use code 62267 with codes for Fine needle aspiration (10022), deep bone biopsy (20225), therapeutic disc decompression (62287), or discography (62290, 62291).

Use code 62287 when the physician is performing a therapeutic removal of disc material percutaneously to ease symptoms of disc compression of adjacent nerves. Code 62287 is used only
once, regardless of the number of levels treated at one session.

Do not report 62287 in conjunction with 62267, 62290, 62311, 77003, 77012, 72295, when performed at same level.

Vertebroplasty, Kyphoplasty & Sacroplasty

Vertebroplasty

Vertebroplasty is a procedure that replaces the vertebral body marrow with cement. It is performed through a percutaneous access.

(A bone needle is placed into the vertebral body from a transpedicular or lateral approach. Bone cement mixed with barium powder is then injected to fill the marrow of the abnormal vertebral body.)

This procedure is performed to treat painful fractured  vertebral bodies usually osteoporotic fractures.

Vertebroplasty is different from kyphoplasty - With kyphoplasty, a cavity is created in the vertebral body for subsequent placement of bone cement. 

Kyphoplasty

Kyphoplasty is a procedure that replaces the vertebral body marrow with cement. 

This is performed via percutaneous access followed by a balloon placement and inflation in the center of the vertebral body. 

A needle is placed into the vertebral body from a transpedicular or lateral approach. Contrast injection is performed to evaluate venous drainage Balloon placement and inflation is performed to create a cavity for cement and to regain the lost vertebral body height.

Arcuplasty uses a bone cutting wire through a side port on the needle to create a cavity for cement placement.

Sacroplasty 

When kyphoplasty, arcuplasty, or vertebroplasty is performed in the sacrum is called as Sacroplasty.

Procedure codes:

CPT 22510 -  Percutaneous vertebroplasty, 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance, cervicothoracic (bone biopsy included when performed).

CPT 22511 - Percutaneous vertebroplasty, 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance, lumbosacral (bone biopsy included when performed).

CPT 22512 - Percutaneous vertebroplasty, 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; each additional cervicothoracic or lumbosacral vertebral body (List separately in addition to code for primary procedure)  + Add on Code.

CPT 22513 - Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance, thoracic

CPT 22514 - Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar

CPT 22515 - Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; each additional thoracic or lumbar vertebral body (List separately in addition to code for primary procedure) + Add on Code.

Notes:

1. When vertebroplasty is performed on both thoracic and lumbar vertebrae, only one initial
level code must be reported for additional level use add on code, even though in a different section of
the spine. Eg. 22510, 22512

            

2. Do not use a -50 modifier when treating one vertebra

3. Do not report 20225, 22315, 22326, 22327 in conjunction with 22510, 22511, 22512, 22513, 22514, 22515, 0200T, 0201T, when performed at the same level)

4.  Vertebral augmentation is the process of cavity creation followed by the injection of the cement under image guidance. Sacral augmentation (sacroplasty) refers to the creation of a cavity within a sacral vertebral body followed by injection of cement to fill that cavity. use 0200T and 0201T.

Use code 0200T for unilateral sacroplasty with or without a balloon device, regardless of sites
treated unilaterally.

Use 0201T for bilateral sacroplasty, regardless of sites treated bilaterally.

5. Do not code deep bone biopsy at the same session and treatment as the vertebroplasty or kyphoplasty, as it is bundled services.

6. Biopsy at a completely separate bone site not treated with vertebroplasty or kyphoplasty would be separately billed.

Gastrointestinal System (GI)

Gastrointestinal System

Physician Places Oral placement of GI tubes under imaging guidance (fluoroscopic) via the mouth or nose which ends in Stomach (Short NasoGastric Tube) or intestine (Long NasoEnteric Tube). some of the eg are mentioned below,

Nasogastric tubes, 

Dobhoff feeding tubes, 

Enteroclysis tubes, 

Blakemore tubes, and 

Miller-Abbott tubes

Short Nasogastric tube placement Procedure Description:

A nasogastric or orogastric tube is inserted through the nose or mouth of the patient into the stomach. The physician use radiological guidance (Fluoroscopic) to advance the tube into the stomach. The tube is connected to a syringe or a suction pump at the external open end to aspirate or drain the stomach contents.

CPT 43752 - Naso or orogastric tube placement, requiring physician's skill and fluoroscopic guidance (Procedure code includes fluoroscopy guidance) 

 

Long Nasoenteric tube placement Procedure Description:

The provider inserts a long flexible intestinal tube that consists of two channels and a balloon tip down to the small intestine. He uses one of the channels in the tube to aspirate, or withdraw, fluid and air for the temporary management of intestinal obstruction.   

The physician inserts a long gastrointestinal tube through the nose and down to the stomach. A weight in the tip of the tube helps maneuver the tube through the pylorus. The provider inflates the balloon which provides enough bulk to pass the tube into the small intestines. The provider sometime uses the CT or ultrasound to guide the insertion and assure placement of the tube. The provider then uses the second channel of the tube to aspirate, or withdraw, fluid and air from the intestines and relieve the obstruction. After an appropriate period of observation, the provider releases the patient.

CPT 44500 - Introduction of long gastrointestinal tube (eg, Miller-Abbott) 

S&I 74340 - Introduction of long gastrointestinal tube (eg, Miller-Abbott), including multiple fluoroscopic films with radiological supervision and interpretation.

CPT 43761 - Repositioning of a naso or orogastric feeding tube, through the duodenum for enteric nutrition, If imaging guidance is performed, use CPT 76000

GI TUBE PLACEMENT 

Gastrointestinal tube placement procedure involves percutaneous placement of a tube directly into the stomach or intestine via the skin.

 

Gastrostomy tube Procedure Description:

Patient is appropriately prepped and anesthetized, the physician inserts an orogastric or nasogastric tube and confirms the position by imaging. She insufflates, or blows air into, the stomach. Under fluoroscopic guidance punctures the abdominal wall and inserts a needle then passes a guide wire through it, and pulls the needle out. he places a dilator to allow serial dilatation of part of the body of the stomach. The physician advances a loop catheter into the stomach and injects contrast at each step to ensure proper placement of the tube and patency of the stomach. After securing the tube, he removes all instruments and applies sterile dressings.

CPT 49440 - Insertion of gastrostomy tube, percutaneous, under fluoroscopic guidance including contrast injection, image documentation and report.

 

Duodenostomy or jejunostomy tube Procedure Description:
Patient is appropriately prepped and anesthetized, the provider uses fluoroscopic guidance to puncture the abdominal wall. He inserts a needle, passes a guide wire through it, and pulls the needle out. He places a dilator to allow serial dilatation of the tract. He inserts and secures the jejunostomy or duodenostomy tube into the small intestine, stitching it in place. After securing the tube, he removes all instruments and applies sterile dressings.

CPT 49441 - Insertion of duodenostomy or jejunostomy tube, percutaneous, under fluoroscopic guidance including contrast injection, image documentation and report 

Cecostomy Procedure Description:

Patient is appropriately prepped and anesthetized, the physician place a catheter in the rectum to inflate the colon during the procedure. The physician makes a small incision on the abdominal wall, assessing the position of the cecum or colon under fluoroscopic guidance. After identifying the position, he directly punctures the cecal or colon by inserting a needle and passes a guide wire through the needle under fluoroscopy. After removing the needle and performing dilatation of the tract, the provider inserts the cecostomy or colonic tube and secures it in the intestinal wall. He may inject contrast at each step to improve visualization under fluoroscopic imaging and ensure proper placement of the tube and patency of the cecum or colon. After completion of the procedure, he applies sterile dressings.

CPT 49442 - Insertion of cecostomy or other colonic tube, percutaneous, under fluoroscopic guidance including contrast injection, image documentation and report.

Note:

All percutaneous gastrointestinal tube placements include the use of Fluoroscopic, Injection of contrast, the images obtained, and the placement of the tube. No need to code S&I separately.

Conversion of gastrostomy tube to gastro-jejunostomy tube procedure description:

Patient is appropriately prepped and anesthetized, the provider uses fluoroscopy to guide placement of a guide wire through the existing gastrostomy tube. The physician removes the gastrostomy tube, uses the existing tract to advance a catheter, and then moves it across the pylorus and into the jejunum. The physician replace the guide wire with a stiffer wire and then use that wire to guide the gastrojejunostomy tube. The physician inject contrast to improve visualization under fluoroscopy and confirm proper tube position in both the jejunum and stomach. Then secures the tube and removes the wires. After completion of the procedure, applies sterile dressings.

CPT 49446 - Conversion of gastrostomy tube to gastro-jejunostomy tube, percutaneous, under fluoroscopic guidance including contrast injection, image documentation and report 

 

BILIARY SYSTEM

Percutaneous Transhepatic Cholangiography (PTHC)

PTHC is a diagnostic study that involves placement of a needle into the Bile duct of liver with Injection of contrast and obtaining imaging.

Procedure description:

Appropriately prepped and anesthetized the patient, the physician uses imaging guidance to pass a needle deep into the liver and into the common bile duct and administer a contrast agent then obtain diagnostic images of the bile ducts. After withdraws the needle, applies a sterile dressing at the site of insertion of the needle.

CPT Code : 47500 

         S&I  : 74320

47500-  Injection procedure for percutaneous transhepatic cholangiography.

74320-  Cholangiography, percutaneous, transhepatic, radiological supervision and interpretation. 

Don't use CPT 47500 for existing catheter cholangiography, Instead use CPT 47505. 

If the physician injecting contrast into the previously placed catheter then it would be appropriate to code CPT 47505 -  Injection procedure for cholangiography through an existing catheter with S&I 74305 - Cholangiography and/or pancreatography; through existing catheter, radiological supervision and interpretation

Biliary Tube Cholangiogram:
Its a Tube checking procedure, where contrast is injected through the previously placed biliary catheter

Biliary Drainage 

Biliary drainage is the insertion of a tube into the bile duct. This is most commonly carried out when the bile ducts are blocked.

External biliary drainage catheters can only drain externally and collected in Bag.

Internal and External biliary drainage catheters can drain externally and internally. 

External Biliary Drainage Procedure description: 

Patient is appropriately prepped and anesthetized and the physician uses imaging guidance to place a needle into the biliary tract that carries digestive juices from the liver, gallbladder, and pancreas to the intestines. Then passes a guide wire through the needle and then using the guide wire inserts a catheter into the bile duct. The physician uses the catheter for drainage of fluids and infected material.

CPT - 47510 - Introduction of percutaneous transhepatic catheter for biliary drainage.
S&I - 75980 - Percutaneous transhepatic biliary drainage with contrast monitoring, radiological supervision and interpretation

Internal and External Biliary Drainage Procedure description: 
Internal and External Biliary Drainage procedure is to drain bile both into the external connected bag as well as internally into the intestine.
Patient is appropriately prepped and anesthetized, the physician uses imaging guidance to place a needle into the biliary site. Then passes a guide wire through the needle and then using the guide wire inserts a balloon catheter into the bile duct. Then physician inflates the balloon to expand and clear the obstruction in the bile duct. The physician then removes the balloon catheter and inserts a stent to prevent the recurrence of obstruction in the bile duct. After the procedure, he ensures hemostasis.

CPT - 47511 - Introduction of percutaneous transhepatic stent for internal and external biliary drainage
S&I - 75982 - Percutaneous placement of drainage catheter for combined internal and external biliary drainage in patients with an inoperable mechanical biliary obstruction, radiological supervision and interpretation.

CPT Code 47511 states transhepatic stent for internal and external drainage. The term stent
refers to a catheter that extends from outside the body into the small bowl, Then stent which cannot be seen from outside assign CPT 47556

CPT 47556 - Biliary endoscopy, percutaneous via T-tube or other tract; with dilation of biliary duct stricture(s) with stent

If a Previously placed External biliary drainage tube is advanced into the duodenum, Use External and Internal Biliary Drainage catheter placement code 47511 with S&I code 75982.

Biliary Catheter Change

If the Biliary catheter is not functioning well or any complication is the indication for catheter change, The catheter is injected with contrast and imaging was obtained then the existing catheter is removed and replaced with a new catheter.

CPT - 47525 - Change of percutaneous biliary drainage catheter 

S&I  -75984 -  Change of percutaneous tube or drainage catheter with contrast monitoring, radiological supervision and interpretation

Biliary Catheter Revision 

 The physician remove and reinsert the same catheter its appropriate to code CPT 47530 - Revision and/or reinsertion of transhepatic tube and S&I code - 75984 (Change of percutaneous tube or drainage catheter with contrast monitoring, radiological supervision and interpretation )

 

DRUG AGENDA - May 2015

 

AmnioPro

Request to establish a unique Level II HCPCS code to identify a human amniotic tissue allograft,
Trade Names: AmnioPro™ Membrane, WoundEx™, BioRenew™ and BioSkin™. 
Applicant's suggested language: Q41XX -AmnioPro Membrane, per cm


Background/Discussion:
    Human Regenerative Technologies, LLC, submitted a request to establish a new code to identify  
AmnioPro Membrane.  According to the requester, AmnioPro membrane is a human amniotic tissue allograft, consisting of dehydrated and decellularized human amniotic membrane that has been processed with proprietary HydraTek technology. AmnioPro thin membrane is designed as a single layer wound covering for common wounds, and AmnioPro thick membrane is designed as a thicker single layer wound covering for deeper wounds where tissue bulk is required. It is intended to be used as a wound covering and is surgically applied to the skin in the treatment of chronic acute and surgical wounds. Both products are available in the following sizes:  1x1cm, 1x2cm, 2x2cm, 2x4cm, 4x4cm, 4x6cm, and 4x8cm. The requester comments that a new HCPCS code is warranted because there are no existing codes that describe AmnioPro membrane.

Preliminary Decision:
    Establish QXXXX, AmnioPro, BioSkin, BioRenew, WoundEx Membrane, per square centimeter.

AmnioPro

Request to establish a unique Level II HCPCS code to identify a human placental tissue matrix
allograft, Trade Names:AmnioPro™ Flow, BioSkin Flow, BioRenew Flow and WoundEx Flow.
Applicant's suggested language: Q41XX - AmnioPro Flow, per cc

Background/Discussion:
   Human Regenerative Technologies, LLC submitted a request to establish a code to identify
AmnioPro Flow.  According to the requester, AmnioPro Flow is  a human placental tissue matrix
consisting of decellularized particulate placental connective tissue matrix intended to replace or
supplement damaged or inadequate integument.  AmnioPro Flow is ideal for use in difficult to
reach, irregularly shaped or tunneled wounds. Typically one application is applied per wound;
however it may be reapplied if necessary. AmnioPro Flow is supplied in the following sizes:
0.5cc, 1.0cc, 1.5cc, and 2.0cc vials.

According to the requester, a new HCPCS code to identify AmnioPro Flow is warranted because
there are no existing codes that describe it

Preliminary Decision:
    Establish QXXXX, "AmnioPro Flow, BioSkin Flow, BioRenew Flow, WoundEx Flow, 0.5cc.








Ref: http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/May-7-2015-DrugAgenda.pdf

DRUG AGENDA - May 2015

AmnioGen-A

       Request to establish two new Level II HCPCS codes to identify injectable liquid placental tissue
matrix:  one to identify a cryopreserved version of the product, AmnioGen – C; and another to identify an ambient version, AmnioGen-A.

Background/Discussion:
       US Biologix, LLC submitted a request to establish two separate HCPCS codes to identify
AmnioGen-C and AmnioGen-A injectable liquid placental tissue Matrix.  According to the requester, both are amniotic membrane product in particulate form obtained fromd onated human placental tissue.  Both are intended to facilitate replacement or supplement damaged or inadequate integumental tissue.  They are intended to be used as a physical wound covering, a foundation for regeneration, modulate correct tissue reconstruction, and to regulate inflammation and pain. Amniotic membranes are a rich source of ExtraCellular Matrix proteins that provide the foundation for the body’s tissues and organs. 

     Both products are prepared by the physician as a suspension with normal saline for injection.  Both are products are supplied as a single-dose vial, and are available in three different doses:  0.5cc, 1.0cc and 2.0cc.  AmnioGen-C is cryopreserved.  AmnioGen-A is ambient.  The requester comments that new codes are warranted because there are no existing codes that describe these products.

Preliminary Decision:
  Establish QXXXX, AmnioGen-C and AmnioGen-A, 0.5cc.

AmnioGen-45

Request to establish two new Level II HCPCS codes to identify an amniotic membrane allograft:
one to identify a 45 micron thick version, AmnioGen-45; and another to identify a 200 micron
thick version, AmnioGen-200.


Background/Discussion:
 US Biologix, LLC submitted a request to establish two separate HCPCS codes to identify AmnioGen-45 and AmnioGen-200 amniotic membrane allografts. Both products are amniotic membrane allografts derived from electively donated placental tissue.  Both grafts are intended to be used as a physical wound covering, a foundation for regeneration, modulate correct tissue reconstruction, and to regulate inflammation and pain.Both are preserved through a proprietary, patented method.  Both are supplied as a single-use biologic available in six different sizes:  1x1 cm, 2x2 cm, 2x4 cm, 4x4 cm, 4x6 cm and 4x8 cm.  AmnioGen membrane comes in two sizes, a thin membrane (45 microns) and a thicker membrane (200 microns). The requester comments that new codes are warranted because there are no existing codes to describe these products. 

Preliminary Decision:
     A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish HCPCS code(s) to separately identify these products, which are 
included as part of the surgical procedure.

MiroDerm

Request to establish a unique Level II HCPCS code to identify a porcine-derived, non-crosslinked  acellular wound matrix, Trade Name: MIRODERM. Applicant's suggested language: Q41XX - MIRODERM, per square centimeter


Background/Discussion:
      A request was submitted on behalf of Miromatrix Medical, Inc. to establish a new code to
identify MIRODERM.  According to the requester, MIRODERM, an extracellular matrix wound
care product.  It is a bioengineered skin substitute derived from porcine liver, processed and stored in a phosphate buffered aqueous solution. MIRODERM is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, drainage wounds, trauma wounds and surgical wounds. It provides a scaffold to maintain and support a healing environment through constrictive remodeling. MIRODERM is supplied in 17 varying sizes, ranging from 4 sq. cm to 200 sq. cm. According to the requester, a new for MORODERM is warranted in order for payers to accurately and efficiently administer claims and coverage policy.


Preliminary Decision:
       A national program operating need was not identified by Medicare, Medicaid or the Private
insurance sector to identify MIRODERM, which is included in the procedure.

Plurivest

Request to establish a unique Level II HCPCS code to identify a human placental connective
tissue matrix, Trade Name Plurivest.  Applicant's suggested language: Plurivest™, per square
centimeter.

Background/Discussion:
   Aedicell, Inc. submitted a request to establish a new code to identify Plurivest.  According to the requester, Plurivest is a human placental connective tissue matrix, available in sizes: 2x3 and 4x4 cm. Plurivest is intended to replace or supplement damaged or inadequate integument.Plurivest may be clinically indicated for patients with partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, drainage wounds and surgical wounds. The attachment protein, growth factor and structural aspects of the placental connective tissue matrix act as a scaffold for cell infiltration and proliferation.

The requester comments that a new HCPCS code is warranted to identify Plurivest because
there is no existing code that describes it.

Preliminary Decision:
    Revise existing code Q4153 which currently reads:  “Dermavest, per square centimeter”, to instead
read:  “Dermavest and Plurivest, per square centimeter”.  The revised code adequately describes the
product that is the subject of this request.

DRUG AGENDA - May 2015

Bio-ConneKt Wound Matrix.

      Request to establish a new Level II HCPCS code to identify bio-ConneKt Wound Matrix.
Applicant's suggested language: Q41XX -Bio-ConneKt Wound Matrix, per square centimeter

Background/Discussion:
      MLM Biologics submitted a request to establish a new HCPCS code to identify Bio-ConneKt
Wound Matrix.  According to the requester,Bio-ConneKt is a bioengineered skin substitute derived from equine Type I collagen. Bio-ConneKt is intended for management of moderately to heavily exuding wounds, including partial and full thickness wounds, draining & tunneling wounds, pressure sores/ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, and surgical wounds.

The product is placed directly into the wound site and incorporates into the wound, as the wound heals. Bio-ConneKt is supplied in 4 different sizes: 6 cm x 7 cm, 5 cm x 5 cm, 3 cm x 3 cm, and 2 cm x 2 cm.  It comes in a double pouch package and in a final outer cardboard envelope.  The product is trimmed to a size slightly larger than the outline of the wound, then affixed to the wound and covered with a standard, non-adherent surgical dressing. The requester comments that a brand-specific code is needed to identify Bio-ConneKT in order for the payers to accurately and efficiently administer claims and benefits.


Preliminary Decision:
    Establish QXXXX, Bio-Connekt Wound Matrix, per square centimeter.

EpiFix

Request to expand the Q41XX code series in order to distinguish coded products based on size
and other product characteristics.  Specifically, to create a coding distinction between Epifix
products that measure more than 20 square centimeters vs. all other (smaller) sizes. 

Applicant’s suggested language:  Revise existing code Q4131 which currently reads “EpiFix, per square centimeter”; to instead read “Human dehydrated amniotic membrane allograft, EpiFIx®,
for sizes up to 20 square centimeters, per square centimeter”; and Establish a new code: QXXXX - Human dehydrated amniotic membrane allograft, EpiFix® for sizes 20 square centimeters and above, per square centimeter.


Background/Discussion:
      MiMedx Group, Inc. submitted a request to revise existing Epifix code Q4131, by adding
language that would limit its application to only product sizes up to 20 square centimeters. 
MiMedx Group also requests the establishment of a new code in the same series to identify Epifix in
sizes 20 square centimeters and above.EpiFix is a multi-layer biologic dehydrated human amnion/chorion membrane allograft comprised of an epithelial layer and two fibrous connective
tissue layers processed from human placenta. 

The processed allograft contains collagen types IV, V and VII that promote cellular differentiation and adhesion. EpiFix is used in wound care where it is necessary to repair or replace lost or damaged human collagen tissue. The actions of EpiFix for wound repair include: providing a matrix for cellular migration/proliferation, promoting increased healing, it is non-immunogenic, natural biological barrier, contains essential growth factors, reduces inflammation, reduces scar tissue, has antibacterial properties and reduces the pain at the site.EpiFix allografts are placed on the wound site and hydrated as necessary. The size needed is determined based upon the size of the wound defect.

The requester claims that existing code Q4131 does is insufficient to accurately describe EpiFix,
because of the wide range and variety of sizes offered, and that coding distinctions based on size
will “facilitate the establishment of a lower payment rate, thus affording medical providers a
more cost effective way to provide the best care to patients with larger wounds.” 


Preliminary Decision:
      Existing code Q4131 "Epifix, per square centimeter" adequately describes the product that is the
subject of your request, and permits reporting of the number of units administered, to accommodate all sizes.

CartiForm

Request to establish a unique Level II HCPCS code to identify an osteochondral allograft, Trade
Name:  Cartiform®.  Applicant's suggested language: JXXXX -1 centimeter squared, Cryopreserved Viable Osteochondral Allograft.


Background/Discussion:
   Osiris Therapeutics submitted a request to establish a HCPCS code to identify Cartiform®. 
According to the requester, Cartiform is a cryopreserved viable osteochondral allograft, processed from donated human osteochondral tissue. Cartiform contains all necessary components for cartilage reconstruction and tissue repair, and is the only cartilage repair product with viable chondrocytes within an intact native cartilage architecture that can be stored frozen for immediate, point-of-care use.It is used to treat articular cartilage defects for a patient population similar to those that would undergo a micro fracture, fresh-stored osteochondral allografting and/or ACI/ Carticel procedures.  Cartiform is safe for patients 55 and younger with at least 6 months of symptoms, radiographic evidence of normal joint space, no evidence of inflammation or osteoarthritis, stable ligaments, adequate meniscus, no malalignment with focal, full thickness Grade 3-4 isolated lesions up to 10 cm caused by acute or repetitive trauma. The surgical technique depends on the defect location, size and physician preference.

Cartiform can be implanted arthroscopically or following an arthrotomy or mini-arthrotomy to expose cartilage defect. The quantity used will vary based upon articular cartilage lesion size and physician recommendation. Cartiform is packaged as a circular disc, stored frozen, and is available in 2 sizes: 20 mm diameter disc and 10 mm diameter disc.

The requester comments that a new code is warranted for Cartiform because there are no HCPCS
codes that accurately describe it.


Preliminary Decision:
      A national program operating need was not identified by Medicare, Medicaid or the Private Insurance sector to establish a HCPCS code to separately identify Cartiform, which is included as part of the surgical procedure. 

DRUG AGENDA - May 2015

Helicoll

Second request to establish a new Level II HCPCS code to identify a bovine collagen acellular dermal matrix,Trade Name: Helicoll™. Applicant's suggested language: Q41XX -Helicoll™ Accellular Dermal Matrix, per square centimeter.


Background/Discussion:
    EnColl Corporation requests a HCPCS code to identify Helicoll, a bovine collagen acellular dermal matrix. Helicoll is a semi-occlusive, self-adhering and sterilized Type-1 collagen sheet for wound treatments, second degree burns, and chronic ulcers.

 It is indicated for use as a topical collagen wound dressing, and topical wound management including partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears, and for surgical wounds, donor sites/grafts, post-Mohs’ surgery, post-laser surgery, podiatric, wound dehiscence).  Biodegradable collagen dressings are derived from animal tissues; they maintain a moist environment that promotes healing and the formation of granulation tissue. Helicoll is individually packaged and intended as a single application for an individual patient. Product should be trimmed to size prior to contact with the patient. It is supplied in a multiple sizes ranging from 2x2 to 6x26 square inches.

The requester comments that prior assignment to codes A6021 and A6023 are inadequate to describe Helicoll, because Encoll revised its description of the product to refer to it as a Bioengineered Acellular Construct, or a Biological Skin Substitute, or as an Acellular Dermal Replacement Matrix, and “the product is not used anymore as a collagen dressing, but as a bioengineered skin substitute,” and is more appropriately coded in the Q41XX code series. 

Preliminary Decision:
   Use existing A6021 "Collagen dressing, sterile, size 16 sq. in. or less, each"; A6022 "Collagen
dressing, sterile, size more than 16 sq. in. but less than or equal to 48 sq. in., each"; or A6023
"Collagen dressing, sterile, size more than 48 sq. in., each,”  based on size,adequately describes the product that is the subject of this request. 

Keramatrix

Request to establish a unique Level II HCPCS Q-code to identify a matrix skin substitute,
Trade Name:  Keramatrix®.  Applicant's suggested language: Q41xx -keramatrix®, per square
centimeter.


Background/Discussion:
   Keraplast Technologies, LLC, submitted a request for a HCPCS code to identify Keramatrix, an open-cell wound dressing comprised of freeze-dried acellular, animal-derived keratin protein.  Keramatrix provides a biocompatible cell-growth substrate or scaffold for growth of new tissue
in three dimensions and is resorbed into the developing tissue.  When a wound occurs, the epithelium
is lost and thus the keratin based skin structure is also lost; keramatrix substitutes the outer layer of the skin by introducing a replacement keratin-based structure. When placed in the wound bed it provides a cell-growth-friendly structure for tissue regeneration and maintains moist wound healing environment.

Through interaction with enzymes in the healing wound, keramatrix is degraded to a gel which is resorbed. Keramatrix is indicated for the patient population with the following types of chronic wounds: pressure ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers and donor sites and grafts. It is supplied in various sizes. 

The requester claims a significant therapeutic distinction between Keramatrix and “Standard Care”
wound products, based on Keramatrix’ combination of moist wound healing, growth-friendly structure and resorption into the wound,causing minimal disturbance to developing tissue. 

The requester comments that, because HCPCS identifiers for skin substitutes are brand-specific,
existing codes do not adequately describe Keramatrix. 

Preliminary Decision:
  Establish QXXXX, Keramatrix, per square centimeter.

Integra

Repeat request to establish a unique Level II HCPCS code to identify INTEGRA®Meshed Bilayer Wound Matrix.  Applicant's suggested language: Integra Meshed Bilayer Wound Matrix, per sq cm.

Background/Discussion:
     Integra LifeSciences Corporation submitted a request  to establish a new permanent code to
identify Integra Meshed Bilayer Wound Matrix (Collagen-Glycosaminoglycan Matrix-Meshed),
and to differentiate it from the non-meshed version of the identical product.  According to the
requester, Integra Meshed Bilayer Wound Matrix is an advanced wound care device comprised
of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan with a
polysiloxane (silicone) layer. Integra Meshed Bilayer Wound Matrix is intended for the
management of wounds including: partial and full-thickness wounds, pressure ulcers, venous
ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, trauma wounds and draining
wounds. The meshed bilayer matrix allows draining of wound exudate and provides a flexible
adherent covering for the wound surface.

Integra Meshed Bilayer Wound Matrix is packaged in sterile, single-use, double peel packages
containing phosphate buffer. It is available in 4 sizes: 500 square centimeters (8”x10” sheets),
250 square centimeters (4”x10” sheets), 125 square centimeters (4”x5” sheets), and 25 square
centimeters (2”x2” sheets).   The product is cut to the size of the wound size and applied
immediately following wound bed preparation. It should be firmly secured using surgical staples,
sutures, or other mechanical means. The requester comments that existing code C9363 is inadequate
for physician office billing, because this code is for use in the Hospital Outpatient setting
(for the purpose of billing Medicare). In order to capture a separate ASP payment the Meshed product
has been assigned to code Q4100 for the purpose of billing Medicare Part B, when used in the physician office setting.  As such, existing code Q4104 has not been assigned for the purpose of billing Medicare


Preliminary Decision:
   Existing code Q4104 "Integra bilayer matrix wound dressing (bmwd), per square centimeter"
adequately describes the product and is available for assignment by insurers, if they deem appropriate, for use in the physician’s office setting.Existing code C9363 “Skin Substitute, Integra Meshed Bilayer Wound Matrix, per square centimeter,” also adequately describes the product, and is available for assignment by insurers, if they deem appropriate, for use in the hospital outpatient setting.  For coding guidance, contact the insurer in whose jurisdiction a claim would be filed.

DRUG AGENDA - May 2015

Cortiva 

Request to establish a new Level II HCPCS code to identify Cortiva™, 1 mm allograft dermis. 
Applicant's suggested language: QXXXX -Cortiva, 1 mm, per square.

Background/Discussion:
    RTI Surgical, dba RTI Biologic, Inc., submitted a request for a new HCPCS code to identify
Cortiva 1mm (allograft dermis).  Cortiva, 1mm is a sterile, dehydrated dermis from donated
human tissue. It is preserved by the Tutoplast process, whereby low-dose gamma irradiation is
applied terminally to the product to achieve a sterility assurance level of 10-6, while preserving
structural integrity. Cortiva, 1mm is an implant regulated as a 361 human cell and tissue product
(HCT/P) and restricted to homologous use for the repair, replacement, reconstruction or
augmentation of soft tissue, including supplemental support and reinforcement of soft tissue in
hernia repair.The requester claims that there are no existing codes that describe Cortiva, 1mm. 
A code is needed in order to process claims and track costs.  Currently, miscellaneous skin substitute code Q4100 is being used to identify this product on claims.

Preliminary Decision:
  A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Cortiva, 1mm, which is
included as part of the surgical procedure.

HPTM

Request to establish a new Level II HCPCS code to identify a porcine-derived, non-cross linked,
cellular dermal matrix surgical mesh, Trade Name HPTM.  Applicant's suggested language: Q41XX -
HPTM, per square centimeter.


Background/Discussion:
      LifeCell Corporation requests the creation of a new HCPCS code to identify HPTM, a sterile,
porcine derived, non-cross linked biologic, acellular tissue matrix surgical mesh. HPTM is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome.  The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery.  Once applied by a surgeon, HPTM supports revascularization, cell repopulation and white cell migration while providing mechanical support. 

The surgeon determines the most appropriate size and shape of HPTM to use on the patient.
Each package contains one piece of HPTM, an outer carton, an outer foil package containing a
sterile inner foil pouch with HPTM. The requester comments that a new code is necessary in order
to provide for greater coding accuracy and utilization documentation for providers and insurers
when billing for the use of this product.


Preliminary Decision:
      A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify HPTM, which is included as
part of the surgical procedure.

Ologen

Repeat request to establish a unique Level II HCPCS Q-code to identify a porcine-derived
collagen matrix, Trade Name:  Ologen®Applicant's suggested language: QXXXX-Ologen®
Collagen Matrix, per unit.

Background/Discussion:
        A request was submitted on behalf of Aeon Astron Europe BV, for a HCPCS code to identify
Ologen Collagen Matrix. According to the requester, Ologen Collagen Matrix is a medical device made of atellocollagen which is derived from porcine skin. This atelocollagen is cross-linked and lyophilized with glycosaminoglycan to obtain Ologen collaten Matrix.  It is configured to support and mudultate wound healing in connective and epithelial ocular tissue, and is used exclusively in ophthalmic surgery procedures such as glaucoma filtering surgery, primarily in the trabeculectomy surgical procedure.

The requester claims that there is a “significant therapeutic distinction” between Ologen and other collagen matrices, in that none of the other matrices are indicated by the FDA for ophthalmic surgery.


Preliminary Decision:
       A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Ologen Collagen Matrix,
which is included as part of the surgical procedure.

DRUG AGENDA - May 2015

Tutopatch

       Request to establish a new Level II HCPCS code to identify Tutopatch™ bovine pericardium.
Applicant's suggested language: QXXXX -  Tutopatch, per square centimeter


Background/Discussion:
   RTI Surgical dba RTI Biologics, Inc., submitted a request for a new code to identify Tutopatch
(Bovine Pericardium). Tutopatch is indicated for use in general and plastic surgery applications.
It is intended for repair of pericardial structures and for use in surgical repair of soft tissue
deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle
flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias
(including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical hernias). 

Tutopatch is preserved by the Tutoplast process, whereby low - dose gamma irradiation is
applied terminally to the product to achieve a sterility assurance level of 10-6, while
preserving structural integrity. This process retains the original three-dimensional collagen
structure responsible for the multidirectional, mechanical properties of tissue. The typical patient
population is persons over the age of 18 who present with soft tissue repair needs.

The requester claims that there are no existing codes that describe Tutopatch. 
A code is needed in order to process claims and track costs.  Currently, miscellaneous
skin substitute code Q4100 is being used to identify this product on claims.

Preliminary Decision:

    A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Tutopatch, which is included
as part of the surgical procedure.

Tutomesh

Request to establish a new Level II HCPCS code to identify Tutomesh™ bovine pericardium.
Applicant's suggested language: QXXXX - Tutomesh, per square centimeter


Background/Discussion:
   RTI Surgical, dba RTI Biologics,Inc.,requests a new code to identify Tutomesh, a fenestrated version of bovine pericardium tissue.  According to the requester, Tutomesh is preserved by the Tutoplast process, whereby low-dose gamma irradiation is applied terminally to the product to achieve a sterility assurance level of 10 -6, while preserving structural integrity. Tutomesh is used in general and plastic surgery applications.

It is a biological scaffold intended to be replaced by newly formed connective tissue through remodeling. 

Tutomesh bovine pericardium is intended for use to reinforce soft tissue where weakness exists
in general and plastic surgery applications and is indicated f or repair of pericardial structures
and for use for surgical repair of soft tissue deficiencies including gastric banding muscle
flap reinforcement, repair of rectal prolapse using an abdominal approach, reconstruction of the
pelvic floor using an abdominal approach, and hernias. The typical patient population is adults
over the age of 18 who present with soft tissue repair needs.

The requester claims that there are no existing codes that describe Tutomesh.  A code is needed
in order to process claims and track costs.  Currently, miscellaneous skin substitute code Q4100
is being used to identify this product on claims.

Preliminary Decision:
     A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Tutomesh, which is included
as part of the surgical procedure.

Cortiva

Request to establish a new Level II HCPCS code to identify Cortiva™, allograft dermis. 
Applicant's suggested language: QXXXX - Cortiva, per square centimeter

Background/Discussion:
       RTI Surgical, dba RTI Biologic, Inc., submitted a request for a new HCPCS code to identify
Cortiva (allograft dermis). Cortiva is a sterile, dehydrated dermis from donated human tissue.
It is preserved by the Tutoplast process, whereby low-dose gamma irradiation is applied terminally
to the product to achieve a sterility assurance level of 10-6, while preserving structural integrity.
Cortiva is an implant regulated as a 361 human cell and tissue product (HCT/P) and restricted to
homologous use for the repair, replacement, reconstruction or augmentation of soft tissue, including
supplemental support and reinforcement of soft tissue in hernia repair.

The requester claims that there are no existing codes that describe Cortiva.  A code is needed in order to process claims and track costs.  Currently, miscellaneous skin substitute code Q4100 is being used to identify this product on claims.


Preliminary Decision:
   A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Cortiva, which is included as
part of the surgical procedure

DRUG AGENDA - May 2015

OMIDRIA (Phenylephrine and ketorolac)

       Request to establish a unique Level II HCPCS code to identify phenylephrine and ketorolac injection 1%/0.3%., Trade Name: Omidria.  Applicant's suggested language: “JXXXX -injection, phenylephrine and ketorolac 1% / 0.3%, 4 mL vial”

Background/Discussion:
   Omeros Corporation submitted a request for a code to identify Omidria.  According to the requester, Omidria is a preservative-free, bisulfite-free, sodium citrate-buffered, sterile drug solution that is added to standard irrigation solution and is used during cataract surgery or other IOL replacement procedures.

It contains 10.16 mg/mL (1%w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial. Omidria is indicated for maintaining pupil size by preventing intraoperative miosis and for reducing postoperative ocular pain.Omidria is currently indicated for use in adults during refractive lens exchange (RLE).

Omidria must be diluted prior to intraocular use.  For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of Omidria is diluted in 500 mL of ophthalmic irrigation solution, to be used as needed for the surgical procedure.  Safety and efficacy of Omidria in pediatric patients has not been established.

Omidria is supplied as a sterile solution concentrate in a clear, 5-mL single-patient-use vial containing 4 mL of sterile solution.Omidria is supplied in a multi-pack containing four single-patient-use vials:NDC 62225-600-04 or ten single-patient-use vials:NDC 62225-6001.According to the applicant, there are no existing HCPCS codes that accurately describe Omidria.


Preliminary Decision:
   A national program operating need was not identified by Medicare, Medicaid or the Private Insurance sector to establish a new HCPCS code to identify Omidria, which is included in surgical the procedure.  Existing code C9447 "

 Injection, Phenylephrine and Ketorolac, 4 ml vial", is available for assignment by insurers if they deem appropriate

AmnioClear

  Request to establish a unique Level II HCPCS code to identify an injectable flowable allograft,
Trade Name:  AmnioClear® LTC.  Applicant's suggested language: J73XX - AmnioClear LTC, per ml.


Background/Discussion:
       Liventa Bioscience requests a new code for AmnioClear.  According to the requester, AmnioClear LTC (loose connective tissue) is minimally processed amniotic tissue.  It is an injectable flowable allograft reduces knee pain and inflammation while also increasing the knee range of motion, lubrication and shock absorption by supplementing the existing knee synovial fluid with human allograft.  

It is intended for use in supplementing synovial fluid in articulating joints. 
The typical dose for viscosupplementation of the knee is 4 mL.  The typical patient-candidate
presents with musculoskeletal joint pain often caused by osteoarthritis.The requester claims that
AmnioClear LTC“is very similar to the viscosupplement products for which HCPCS codes have been established (J7321 to J7327) and therefore should be treated as a drug or biological.

The typical dose for injection into the knee as a viscosupplement is 4ml. A 2ml injection may be
appropriate for smaller patients.AmnioClear LCT comes in 1ml, 2ml, and 4ml vial sizes. 
The requester comments that a new code in the J73XX seectin is warranted because there is
currently no code that describes the human tissue-based viscosupplement product by the brand - name AmnioClear LCT, while there are numerous brand-specific codes for viscosupplement products.

Preliminary Decision:
      A national program operating need was not identified by Medicare, Medicaid or Private
Insurance sector to establish a HCPCS code to identify AmnioClear®LCT.  This product is not
FDA cleared for the indication specified in the code application

Fortiva

Request to establish a unique Level II HCPCS code to identify an extracellular collagen matrix
surgical mesh derived from porcine dermis, Trade Name:  Fortiva.  Applicant's suggested
language: QXXXX - Fortiva, per square centimeter

Background/Discussion:
    RTI Surgical dba RTI Biologics, Inc., submitted a request to establish a new HCPCS code to
identify Fortiva, a porcine-derived extracellular collagen matrix.  Fortiva is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. 

Indications for use include the repair of hernias and/or body wall defects which require the use
of reinforcing or bridging material to obtain he desired surgical outcome.  According to the requester,
Fortiva performs as a scaffold that allows for neovascularization and permits the replacement
of the porcine dermis with the patient's tissue. The matrix is derived from porcine dermis and
preserved using a multi-step sterilization process which includes terminal sterilization by
gamma irradiation. Fortiva is provided hydrated and is ready for immediate use without additional
preparation. As a surgical mesh, Fortiva is hydrated and stored at 10-30 degrees Celsius.

The typical patient population is persons over age 18 who present with soft tissue repair needs.
The requester claims that there are no existing codes that describe Fortiva.  A code is needed in
order to process claims and track costs .  Miscellaneous skin substitute code Q4100 is currently
being used to identify this product on claims.

Preliminary Decision:
       A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish a HCPCS code to separately identify Fortiva, which is included as part of the surgical procedure.



Ref: http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/May-7-2015-DrugAgenda.pdf

DRUG AGENDA - May 2015

ADASUVE  (Loxapine)

      Request to establish a new Level II HCPCS code to identify loxapine, Trade Name: 
Adasuve.  Applicant’s suggested language:  “JXXXX Loxapine, inhalation powder, 10 mg.

Background/Discussion:
     Teva Pharmaceuticals requests a new Level II HCPCS code to identify for loxapine.  According
to the requester, loxapine is an atypical antipsychotic drug supplied as a powder for oral
inhalation, indicated for the acute treatment of agitation associated with schizophrenia or bipolar
I disorder in adults.  “Psychomotor agitation” is defined in DSM - IV as “excessive motor activity
associated with a feeling of inner tension.”  Patients experiencing agitation often manifest
behaviors that interfere with their care (e.g., threatening behaviors; escalation or urgently
distressing behavior; self - exhausting behavior), leading clinicians to use a rapidly absorbed
antipsychotic medication to achieve immediate control of the agitation.  To limit the risk of
serious side effects such as bronchospasm, use of Adasuve must only be used in healthcare
facilities enrolled in the Adasuve Risk Evaluation and Mitigation Strategy (REMS) Program
that have immediate (on-site) access to equipment and personnel trained to manage acute
bronchospasm, including advanced airway management (intubation and mechanical ventilation). 
Adasuve is administered in a single breath inhalation via a single - use, disposable, handheld
inhaler that contains the drug.  Patients are instructed to hold the inhaler away from their mouth
and exhale fully, then put the mouthpiece of the inhaler between their lips, close their lips and
inhale with a single steady, deep breath, remove the mouthpiece and hold their breath for up to
10 seconds.

The applicant comments that a new code is warranted because there are no existing “J”
codes to describe this formulation and delivery method of loxapine. 

Preliminary Decision:
     A national program operating need was not identified by Medicare, Medicaid or Private Insurers
to establish another Level II HCPCS code to identify Adasuve.  Existing code C9497 “Loxapine,
inhalation powder, 10 mg” is available for assignment by insurers if they deem appropriate.  

VIZAMYL (Flutemetamol)

         Request to establish a unique Level II HCPCS code to identify Flutemetamol F18 Injection,
Trade Name:  Vizamyl. 

Background/Discussion:
GE Healthcare submitted a request to establish a new Level II HCPCS code to identify
Flutemetamol F18 Injection (Vizamyl).  According to the requester, Vizamyl is
a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging
of the brain to estimate Beta Amyloid neuritic plaque density in adult patients with
cognitive impairment who are being evaluated for Alzheimer’s disease (AD), or other causes
of cognitive decline.  A negative Viazmyl scan indicates sparse to no neurotic plaques,
and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition.
 A negative scan reduces the likelihood that a patient’s cognitive impairment is a result of AD. 
A positive Vizamyl scan indicates moderate to frequent amyloid neuritic plaques;
neuropathological examination has shown this amount of neuritic plaque is present in patients with A
D, but may also be present in patients with other types of neurologic conditions,
as well as older people with normal cognition.  Vizamyl is an adjunct to other diagnostic evaluations. 
There are, however; some limitations of use. 
A positive Vizamyl scan does not establish a diagnosis of AD or other cognitive disorder. 

Recommended dose is 185 megabecquerels (MBq) [5 millicuries (mCi)]; maximum mass dose
20 micrograms] in a maximum dose volume of 10 mL, administered as a single intravenous
bolus within 40 seconds, followed by an intravenous flush of 0.9% sterile sodium chloride
injection.  It is supplied in a 10 mL or a 30 mL multi-dose vial with 1 -10 mL and 1-30 mL fill
volume respectively.  Each vial is enclosed in a radiation shield.  The total concentration is 150
MBq/mL (4.05 mCi/mL) of flutemetamol F 18 at reference date and time.The applicant comments that a new code
is warranted because no existing HCPCS code accurately describes this product. 


Preliminary Decision:
   Existing code A9599 “Radiopharmaceutical, diagnostic, for beta - amyloid positron emission
tomography (PET) imaging, per study dose” adequately describes the product that is the subject
of this request.

NEURACEQ (Florbetaben)

   Request to establish a unique Level II HCPCS code to identify florbetaben F 18, Trade
Name:  Neuraceq.  Applicant’s suggested language:  “AXXXX Injection, florbetapen F 18,
diagnostic, per study dose, up to 8.1 millicuries”.

Background/Discussion:
   Piramal Pharma, Inc., submitted a request for a new code to identify Neuraceq (florbetaben F 18).
According to the applicant, Neuraceq is a radioactive diagnostic agent indicated for Positron
Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density
in adult patients with cognitive impairment who are being evaluated for AD and other causes of
cognitive decline. Florbetaben binds to β-amyloid plaques in the brain. This produces a position
signal that is detected by a PET scanner. Neuraceq is administered by intravenous injection.
Recommended dosage is a single IV bolus of 300 MBq of Neuraceq followed 45-130 minutes afterwards
by brain PET imaging for 15 - 20 minutes in duration. Neuraceq is supplied in 30 mL multi-dose vial
s containing 50 to 5000 MBq/mL (1.4 to 135 mCi/mL) florbetaben F 18 at EOS. 
At time of administration, 300 MBq (8.1 mCi_ are contained in up to 10 mL of solution for injection.  

The applicant claims that there is a significant therapeutic distinction between Amyvid and Vizamil
–and Neuraceq.  All three of these products have different dosages; there is also a difference between
the mean effective radiation dose of Neuraceq and Vizamyl and the mean effective radiation dose of Amyvid.  
The applicant claims that, as per prior CMS HCPCS coding determination, existing code A9599,
Radiopharmaceutical, diagnostic, for beta-amyloid positron emission tomography (pet) imaging , per study dose
does not accurately describe Neuraceq, because the descriptor is not specific to the active ingredient, florbetaben F 18.


Preliminary Decision:
Existing code A9599 “Radiopharmaceutical, diagnostic, for beta-amyloid positron emission
tomography (PET) imaging, per study dose” adequately describes the product that is the subject of this request.


Ref: http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/May-7-2015-DrugAgenda.pdf

DRUG AGENDA - May 2015

ZARXIO 

       Request to establish a new Level II HCPCS code to identify Zarxio, a biosimilar to the reference
drug Filgrastim.  Applicant’s suggested language:  “JXXXX Injection, Filgrastim, Zarxio 1 mcg”

Background/Discussion:

       The applicant states that a new code is warranted and makes the following claims:  no existing
HCPCS codes describe Zarxio; biosimilar products “must be separated”, via HCPCS coding; and
biosimilar products should be considered single source drugs and as such, receive unique codes. 

Preliminary Decision:

        Establish new code Q5101 Injection, Filgrastim (G-CSF), Biosimilar, 1 microgram.  Effective
7/1/15.

VARITHENA

       Second request to establish a new Level II HCPCS code to identify Low-nitrogen 1%
Polidocanol injectable foam, Trade Name:  Varithena.  Applicant’s suggested language: 
“JXXXX Low Nitrogen 1% Polidocanol Injectable foam: Sterile canister, 1 ml.”   

Background/Discussion:

       Provensis Ltd., submitted a request for a new HCPCS code to identify Varithena. 
According to the requester, Varithena is a drug-device combination low
-nitroben 1% Polidocanol sclerosant, used for the treatment of incompetent great saphenous veins,
accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system
above and below the knee. The foam is generated from a proprietary canister system
and is composed of a gas and liquid phase. The foam displaces blood from the target vein
and the polidocanol within the foam scleroses the endothelium. 
Varithena is intended for intravenous injection using ultrasound guidance,
administered via a single cannula into the lumen of the target incompetent trunk vein or by direct
injection into varicosities.The hydrophobic pole of the polidocanol molecule attaches to the
lipid cell membrane of the venous enfothelium and vasospasm.    

Following exposure to polidocanol, the interior surface of the vein becomes thrombogenic,
which leads to thrombus formationand venous occlusion. The occluded vein is eventually
replaced by fibrous connective tissue. Polidocanol is deactivated upon contact with blood,
thus limiting the sclerosant action to the endothelium near the site of injection.

Varithena is supplied in a Tyvek pouch containing two sterile, connected 303 mL aluminum
alloy canisters, one containing polidocanol solution and one containing pressurized oxygen at
approximately 5.4 bar absolute. The connector joins the two canisters and allows activation of
the product.  Upon activation, the multi-use canister generates 45 ml of usable foam.  Up to 5mL
can be used per injection and no more than 15 mL should be used per session.

The applicant claims that a new code is warranted for the following reasons:
 1) no existing code describes Varithena;
 2) due to “poor J coding”, claims cannot be timely processed and physicians
or patients are not paid in a timely manner, (patients have to sign an ABN due to “inadequate J-
coding”; 3) neither CPT codes nor miscellaneous J codes allow “optimal dosing”, or tracking of
clinical outcomes.   

Preliminary Decision:

     Level II HCPCS is not the appropriate coding jurisdiction for this product.  The miscellaneous
CPT code used to report the physician’s office procedure includes all items used, including the
Varithena. Separate coding and billing for Varithena using a “J” code or any other Level II
HCPCS code is duplicative and inappropriate.  Having patients sign an ABN for a product that is
included in the CPT is also inappropriate

ALBUTEROL SULFATE INHALATION SOLUTION

       Request to establish a new Level II HCPCS code to identify Albuterol Sulfate Inhalation
Solution, 0.5% concentrate.   Applicant’s suggested language:  “Albuterol, Inhalation Solution,
fda- approved final product, non - compounded, administered through DME, concentrated form,
unit dose, 0.5 mg (Albuterol non - comp unit).”

Background/Discussion:

       Nephron Pharmaceuticals Corporation requested a new HCPCS code to identify for Albuterol
Sulfate Inhalation Solution, .5% concentrate. According to the requester, the drug is indicated
for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive
airway disease and acute attacks of bronchospasm. Albuterol stimulates adenyl clyclas, the
enzyme that catalyzes the formation of cyclic -3’, 5’- adenosine monophosphate (cyclic AMP)
from adenosine triphosphate (ATP) in beta - adrenergic cells. The cyclic AMP thus formed
mediates the cellular responses. Increased cyclic AMP levels are associated with relaxation of
bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity
from cells, especially from mast cells

The typical dosage for adults and pediatric patients 12 years of age and older is 2.5 mg (one unit
- of - use vial) administered 3 to 4 times daily by nebulization. Albuterol Sulfate Inhalation Solution
is supplied in  sterile, “unit - of - use” vials of 0.5 mL each, supplied in individual foil pouches; 30
pouches in one package.

The applicant claims that there is no existing code to identify a concentrated form
in unit dose packaging, as such, a new code is warranted.
 

Preliminary Decision:

       Existing code J7611 “Albuterol, Inhalation Solution, FDA - approved final product
, non - compounded, administered through DME, concentrated form, 1 mg”, adequately describes the
product that is the subject of this request


Ref:
http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/May-7-2015-DrugAgenda.pdf

CRITICAL CARE SERVICES

CRITICAL CARE SERVICES

           Critical care is the direct delivery by a physician(s) or other qualified health care professional of medical care for a critically ill or critically injured patient.

           A critical illness or injury acutely impairs one or more vital organ systems such that there is a high probability of  life threatening deterioration in the patient's condition.

           Critical care involves high complexity decision making to assess, manipulate, and support vital system function to treat single or multiple vital organ system failure and/or to prevent further life threatening deterioration of the patient's condition.

Examples of vital organ system failure include, but are not limited to, central nervous system failure, circulatory failure, shock, renal, hepatic, metabolic, and/or respiratory failure.

Although critical care typically requires interpretation of multiple physiologic parameters and/or application of advanced technology(s), critical care may be provided in life threatening situations when these elements are not present.

Critical care may be provided on multiple days, even if no changes are made in the treatment rendered to the patient, provided that the patient's condition continues to require the level of attention described above.

Providing medical care to a critically ill, injured, or post-operative patient qualifies as a critical care service only if both the illness or injury and the treatment being provided meet the above requirements.

Time spent with the individual patient should be recorded in the patient's record.

CPT 99291- Critical care, evaluation and management of the critically ill or critically injured patient; first 30-74 minutes

CPT 99292- Critical care, evaluation and management of the critically ill or critically injured patient; each additional 30 minutes (List separately in addition to code for primary service)

Inpatient critical care services provided to infants 29 days through 71 months of age are reported with pediatric critical care codes 99471- 99476

The pediatric critical care codes are reported as long as the infant/young child qualifies for critical care services during the hospital stay through 71 months of age.

Inpatient critical care services provided to neonates (28 days of age or younger) are reported with the neonatal critical care codes 99468 and 99469.

The neonatal critical care codes are reported as long as the neonate qualifies for critical care services during the hospital stay through the 28th postnatal day.

The reporting of the pediatric and neonatal critical care services is not based on time or the type of unit (eg, pediatric or neonatal critical care unit) and it is not dependent upon the type of physician or other qualified health care professional delivering the care.

To report critical care services provided in the outpatient setting (eg, emergency department or office), for neonates and pediatric patients up through 71 months of age, see the critical care codes 99291, 99292.

 If the same individual provides critical care services for a neonatal or pediatric patient in both the outpatient and inpatient settings on the same day, report only the appropriate neonatal or pediatric critical care code 99468-99472 for all critical care services provided on that day.

Also report 99291-99292 for neonatal or pediatric critical care services provided by the individual providing critical care at one facility but transferring the patient to another facility.

Critical care services provided by a second individual of a different specialty not reporting a per day neonatal or pediatric critical care code can be reported with codes 99291, 99292.

For additional instructions on reporting these services, see the Neonatal and Pediatric Critical Care section and codes 99468-99476. Services for a patient who is not critically ill but happens to be in a critical care unit are reported using other appropriate E/M codes.

            Critical care services include the treatment of vital organ failure or prevention of further life–threatening conditions. Delivering medical care in a moment of crisis and in time of emergency is not the only requirement for providing CC services. Presence of a patient in an ICU or use of ventilation is not sufficient to bill a CC service.

The following three criteria must be met for reporting CC service:

            1.       The severity of illness

            2.       The intensity of services required treating the illness, and

            3.       The time spent in providing the care.

Proper documentation showing the medical necessity for providing CC services is an absolute requirement.

Usually a critical care service is provided to a patient in a "critical care area" such as the

        1.       Coronary care unit (CCU),

        2.       Intensive care unit (ICU),

        3.       Respiratory care unit, or

        4.       Emergency room.

This code is applicable for a critical care service provided for first 30 – 74 minutes. Any CC service provided for less than 30 minutes should be billed with the appropriate level of E/M code.

Critical care services require a cumulative time of at least 30 minutes on a given date of service

– Time can be continuous or intermittent on the date of service and must be clearly documented in the medical record.

     The total time can be calculated by the time spent evaluating, managing, and providing critical care services to a critically ill or injured person.

     The time to be billed for CC must be spent at the immediate bedside or elsewhere on the floor as long as the physician is available to the patient. Full attention of a physician must be paid towards the CC service

This code is applicable for patients 25 months of age and older.

Inclusive Services:

The following services are included in "critical care service" time when performed during the critical period by the same physician(s) providing critical care and should not be reported separately:

          1.       The interpretation of cardiac output measurements (93561,93562)

          2.       Pulse oximetry (94760, 94761, 94762)

          3.       Chest x–rays, professional component (71010, 71015, 71020)

          4.       Blood gases, and information data stored in computers (e.g., ECGs, blood pressures, hematologic data–CPT 99090)

          5.       Gastric intubation (43752, 91105)

          6.       Transcutaneous pacing (92953)

          7.       Ventilator management (94002–94004, 94660, 94662)

          8.       Vascular access procedures (36000, 36410, 36415, 36591, 36600)

Code 99291 is used to report the first 30-74 minutes of critical care on a given date. It should be used only once per date even if the time spent by the individual is not continuous on that date. 

Critical care of less than 30 minutes total duration on a given date should be reported with the appropriate E/M code. 

Code 99292 is used to report additional block(s) of time, of up to 30 minutes each beyond the first 74 minutes. 

 

The following examples 

30-74 minutes (30 minutes - 1 hr. 14 min.) 99291 X 1 

75-104 minutes   (1 hr. 15 min. - 1 hr. 44 min.) 99291 & 99292 X 1 

105-134 minutes (1 hr. 45 min. - 2 hr. 14 min.) 99291 & 99292 X 2 

135-164 minutes (2 hr. 15 min. - 2 hr. 44 min.) 99291 & 99292 X 3 

165-194 minutes (2 hr. 45 min. - 3 hr. 14 min.) 99291 & 99292 X 4

GENITOURINARY SYSTEM (GU)

Non Vascular Interventional Coding

Genitourinary System (GU)

      There are various non vascular Interventional procedures are performed for various conditions which are related to GU system are mentioned below, some of the common Terminology are:

Pyelography:  X ray images of the renal pelvis of the kidney with associated structures after administration of a contrast agent.

Nephrostomy tube:  A very small, soft, plastic tube, which is placed into the renal collecting system for temporary drainage of urine, abscess, or calculus removal.

Pyelostomy tube:   A plastic tube which is placed in the renal pelvis of the kidney for drainage of urine. It is placed either percutaneously or during an open surgical procedure.

Nephrostogram:   An X ray of the kidney after injection of a contrast agent.

Pyeloureterogram:  An X ray of the kidneys, renal pelvis, and ureters after injection of a contrast agent.

Percutaneous Antegrade Pyelogram

A Percutaneous Antegrade Pyelogram  is performed by placing a needle into the kidney or kidney cyst with injection of contrast and taking images.

 CPT 50390- Aspiration and/or injection of renal cyst or pelvis by needle, percutaneous
 For radiological S&I, - 74425,74470, 76942, 77002, 77012, 77021. 

Note:
Don't assign antegrade pyelogram if contrast injection was performed for the purpose of
localization of a posterior calyx for subsequent Percutaneous nephrostomy tube placement.

Nephrostomy Tube Placement

Renal collecting system obstruction would be the major reason behind the placement of Percutaneous nephrostomy tube placement. The procedure consist of placement of a drainage tube into the collecting system of an obstructed kidney. The tube is sutured in place and drains to a bag at the patient’s side.

CPT 50392 - Introduction of intracatheter or catheter into renal pelvis for drainage and/or injection, percutaneous

For radiological S&I, - 74475, 76942, 77012

Note:
If both a diagnostic antegrade pyelogram and a nephrostomy tube placement are performed at
the same session, code 50392 and 50390 with 59 modifier along with appropriate S&I codes.

(The diagnostic antegrade pyelogram is via the initial needle puncture of the collecting system, followed by a new separate percutaneous puncture of a posterior calyx for placement of the drainage catheter)

Nephrostogram

Malfunctioning drainage tube or any complication would be the reason for Nephrostogram procedure following prior Percutaneous nephrostomy tube placement. Nephrostogram involves injection of contrast into a newly placed or pre-existing kidney drainage tube and analyze the internal structures of the kidney, renal pelvis, and/or ureter using imaging guidance.

 

CPT 50394 - Injection procedure for pyelography (as nephrostogram, pyelostogram, antegrade pyeloureterograms) through nephrostomy or pyelostomy tube, or indwelling ureteral catheter

 

For radiological S&I, - 74425

 

Note:  If a tube check or change is performed with the patient in the supine position, it is  via an ileal conduit and is coded with 50684 or 50688.

 

           If a tube check or change is performed with the patient in the prone position, the procedure is performed via flank and is coded with 50394. 

 

Nephrostomy Tube change

Non-functioning nephrostomy tube is the reason behind the Nephrostomy Tube change, Nephrostomy tube is evaluated first by administrating contrast through the existing Nephrostomy Tube (NEPHROSTOGRAM) and The exchange portion of the exam occurs when a wire is placed through the existing tube and the tube is removed, followed by placement of a new tube into the kidney over the wire.

 

CPT 50398 - Change of nephrostomy or pyelostomy tube

 

For radiological S&I, - 75984

 

Note: In case contrast was not documented don't assign 75984 instead can code 76000.